ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial

NCT07278947 | Not Yet Recruiting DMC

• 1 other identifier: LYEC2025-0209
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT) approach to enhance the mental well-being and parenting competence of parents of children with hearing loss post-cochlear implantation over a three-month period after the intervention has taken place.

Conditions

Hearing Loss; Stress; Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Parental Stress

  The Parental Stress Scale (PSS, 18-item, 5-point scale) will assess parenting stress. A higher score represents a higher level of parental stress. The Chinese version of the PSS has demonstrated acceptable psychometric properties and is therefore suitable for use by researchers to assess the parental stress levels of Chinese parents.

  Change from baseline assessment to immediate post-intervention

Secondary Outcomes (5)

• Parental depressive symptoms

  Change from baseline assessment to immediate post-intervention

• Parental anxiety symptoms

  Change from baseline assessment to immediate post-intervention

• Parental Psychological Flexibility

  Change from baseline assessment to immediate post-intervention

• Parenting competency

  Change from baseline assessment to immediate post-intervention

• Satisfaction of the intervention

  This outcome will be assessed 1-2 weeks after the end of the intervention.

Study Arms (2)

ACT-based parenting program+usual care

EXPERIMENTAL

Parents will receive 6 ACT-based parenting program sessions, one weekly session, 45-60 mins per session. These sessions will be one-on-one, conducted via video conferencing.

Behavioral: ACT-based parenting program+usual care

Usual care

ACTIVE COMPARATOR

Parents will receive usual care delivered by otology nurses regarding post-cochlear implantation care instructions.

Other: Usual care

Interventions

ACT-based parenting program+usual care BEHAVIORAL

The ACT-based parenting program integrates two complementary components: (1) targeted psychoeducation on post-CI care (device use and troubleshooting, home-based auditory rehabilitation, realistic progress monitoring, school and social participation, communication strategies, and navigation of rehabilitation services); and (2) brief, skills-focused psychotherapeutic content grounded in ACT principles to enhance psychological flexibility (e.g., present-moment awareness, defusion from difficult thoughts, acceptance of difficult emotions and sensations, values clarification, and committed action in daily caregiving). By combining condition-specific knowledge with process-based skills, the intervention is designed to address both informational needs and core psychopathological processes that perpetuate caregiver distress.

ACT-based parenting program+usual care

Usual care OTHER

Parents in the control arm will receive usual care delivered by otology nurses covering post-cochlear implantation care instructions (e.g., device safety, basic troubleshooting, follow-up schedules) and will have access to standard rehabilitation services as per clinic routines. After final assessments, waitlist participants may be offered access to intervention materials where appropriate.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mandarin-speaking Chinese residents aged ≥18 years.
• Their child is scheduled to undergo cochlear implant surgery within the next month or has undergone cochlear implant surgery within the past month.
• Living with their child with hearing loss who uses (or will use) a cochlear implant.
• Primary caregiver responsible for the child's daily care.
• Has reliable internet access via a computer and/or smartphone for video-conferencing (e.g., TenCent Meeting, Zoom) and is willing to maintain access for the duration of the intervention.

You may not qualify if:

• Parents with cognitive deficiency, severe mental illness and/or disability conditions that interfere with their ability to comprehend the programme's content.
• Current substance or alcohol dependence.
• Pregnancy or postpartum period (\<6 months).
• Participation in any ACT-based intervention within the past six months.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• Xiangya Hospital of Central South University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator

MeSH Terms

Conditions

Hearing Loss; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Sini LI, PhD

CONTACT

86-17375843150; lisini_audrey@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible parents consenting to participate will be randomly assigned to either the Intervention (ACT-based parenting program) or Control (usual-care) Group in a 1:1 ratio, using the permuted block size of 4 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nurse

Model Details: Two arm, pretest posttest, assessor blinded Randomised Controlled Trial (RCT)

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: March 28, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share